TORONTO, April 11, 2012 /PRNewswire/ – Today, Biogen Idec Canada announces that FAMPYRA (fampridine sustained release tablets or fampridine SR) is now available for prescription for patients living with multiple sclerosis (MS) in Canada. Health Canada approved FAMPYRA on February 10, 2012 for the symptomatic improvement of walking in adult MS patients with walking disability (EDSS 3.5-7).1 Walking impairment is one of the most common and disruptive consequences of MS2 and FAMPYRA is the first approved treatment that addresses this unmet medical need. In clinical trials, it demonstrated efficacy in people with all types of MS.3
Patients with MS consistently rate walking as the most important function they want to maintain, regardless of what stage they are in their disease.4 Walking impairment is directly associated with loss of independence, restrictions on a patient’s ability to work and a reduction in overall levels of household income.5 In fact, a research survey shows that 88 per cent of sampled Canadians living with MS report that difficulty walking affects their overall mobility.6
“For patients with MS, one of the greatest areas affected in their lives is walking. Until fampridine SR (Fampyra), there have been no pharmacologic agents shown to directly improve walking function in persons with multiple sclerosis,” said Dr.Christine Short, Associate Professor, Department of Medicine, Division of Physical Medicine and Rehabilitation, Dalhousie University, Halifax, NS. “As a clinician who manages persons with multiple sclerosis, the approval of this treatment in Canadarepresents a real breakthrough in our battle to help individuals maintain independence and quality of life in the face of a progressive neurologic disease.”
MS is an unpredictable, often debilitating disease of the central nervous system that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage.7 When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted.8 Studies show that FAMPYRA can increase conduction along damaged nerves and enable signals to pass down the nerve more normally, which may result in improved walking for adult MS patients.9
Clinical Data Demonstrates Efficacy
The approval of FAMPYRA for the improvement of walking in adult patients with MS was based on the results of two Phase III clinical trials: MS-F203 and MS-F204.10 The primary endpoint was the responder rate based on walking speed as measured by the Timed 25-Foot Walk (T25FW).11 A significantly greater proportion of patients taking FAMPYRA had consistent improvement in walking speed when compared to placebo (MS-F203: 34.8 per cent to 8.3 per cent, and MS-F204: 42.9 per cent to 9.3 per cent).12 In patients who responded to therapy in the two studies, MS-F203 and MS-F204, FAMPYRA increased their walking speed on average by 26.3 per cent to 5.3 per cent on placebo, and 25.3 per cent to 7.8 per cent, respectively.13
The approval of FAMPYRA for the improvement of walking in adult patients with MS was based on the results of two Phase III clinical trials: MS-F203 and MS-F204.10 The primary endpoint was the responder rate based on walking speed as measured by the Timed 25-Foot Walk (T25FW).11 A significantly greater proportion of patients taking FAMPYRA had consistent improvement in walking speed when compared to placebo (MS-F203: 34.8 per cent to 8.3 per cent, and MS-F204: 42.9 per cent to 9.3 per cent).12 In patients who responded to therapy in the two studies, MS-F203 and MS-F204, FAMPYRA increased their walking speed on average by 26.3 per cent to 5.3 per cent on placebo, and 25.3 per cent to 7.8 per cent, respectively.13
“Seeing the effects of these results will have an important impact on patients,” said Dr. Brad Stewart, Neurologist and Assistant Clinical Professor, University of Alberta, Edmonton, Alberta. “As mobility impairment in MS is progressive, Fampyra is a welcomed, new treatment to address this unmet need in the management of walking difficulties.”
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